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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2025-02815 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 19PS-24-7 | Other Identifier | USC / Norris Comprehensive Cancer Center | |
| P30CA014089 | U.S. NIH Grant/Contract | View source | |
| U2CCA252971-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This clinical trial evaluates the effectiveness of trained community engagement specialists for improving communication on colorectal cancer (CRC) prevention and genetic testing among Hispanic/Latino/a/x (H/L) communities. CRC is the second and third leading cause of cancer deaths among United States (US) H/L men and women respectively. Knowledge of inherited germline mutations (changes in a gene that occurs in a sperm or egg cell) is critical for understanding cause of disease and can impact patient treatment options and outcomes. Educational programs and participant engagement approaches focused on H/L individuals considering Latino cultural values, literacy, numeracy, barriers faced, cultural beliefs and attitudes, as well as language of participants are much needed to address these observed disparities. The Community Genetic Navigation Specialists (CoGENES) Program focuses on increasing knowledge, and preparing the CoGENES trainees to help respond to questions, fears, and concerns regarding genetic testing, counseling, biospecimen (sample of urine, blood, or tissue cells) donation and participation in clinical trials to H/L community members, patients and their families. CoGENES may improve communication on colorectal cancer prevention and genetic testing which can help reduce cancer disparities among H/L communities.
PRIMARY OBJECTIVE:
I. To develop a local workforce of trained community engagement specialists to act as liaison agents to improve communication on genetic research, clinical genetic testing, and counseling to Hispanic/Latino/a/x (H/L) individuals.
OUTLINE: Participants are randomized to 1 of 2 groups.
GROUP 1: Participants receive a packet of existing information materials about colorectal cancer prevention, screening, and genetic testing to review at their own pace over 6-10 weeks. Participants may optionally receive a CoGENES training session within 2 weeks post-intervention.
GROUP 2: Participants receive a CoGENES training session over 45-60 minutes.
After completion of study intervention, participants are followed up at 8 weeks, 6 months and 12 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 (usual care) | Active Comparator | Participants receive a packet of existing information materials about colorectal cancer prevention, screening, and genetic testing to review at their own pace over 6-10 weeks. Participants may optionally receive a CoGENES training session within 2 weeks post-intervention. |
|
| Group 2 (CoGENES) | Experimental | Participants receive a CoGENES training session over 45-60 minutes. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Best Practice | Other | Receive a packet of existing information materials about colorectal cancer prevention, screening, and genetic testing |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in knowledge about colorectal cancer prevention | We will use the WCRF/AICR score, which is a standardized scoring system, typically ranging from 0 to 7 points, that measures an individual's adherence to the World Cancer Research Fund (WCRF) and American Institute for Cancer Research (AICR) recommendations for cancer prevention. A higher score indicates greater compliance with lifestyle factors like maintaining a healthy weight, engaging in physical activity, eating a diet rich in plant-based foods, and limiting alcohol, fast food, and sugary drinks. We will compare pre- and post-intervention to assess knowledge. | Baseline to 12 months |
| Change in knowledge about genetic testing | Will use the Genetic Literacy and Comprehension (GLAC) measure to assess participant knowledge with eight commonly used genetic terms and concepts (genetic, chromosome, susceptibility, mutation, variation, abnormality, heredity, and sporadic) using a 7-point scale of 1 "Strongly Disagree" to 7 "Strongly Agree". We will compare pre- and post- surveys to assess knowledge. | Baseline to 12 months |
| Change in knowledge about tumor testing | Will assess participants knowledge about tumor testing as determined by scores obtained from validated surveys. Will compare pre- and post- surveys to assess knowledge. Higher scores mean better knowledge. | Baseline to 12 months |
| Change in knowledge about genetic counseling | There are 14 items in the questionnaire of Cancer Genetic Knowledge Scale. The total score ranges between 14 and 70. Higher scores indicate more/better knowledge. The questionnaire will be administered at pre- and post-genetic education. | Baseline to 12 months |
| Changes in dietary and lifestyle patterns | Measured by scores obtained from surveys developed for this study. Will compare pre- and post- surveys to evaluate changes. Higher scores mean positive changes. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bianca Rosales | Contact | 323-865-0811 | Biancar@usc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Mariana C Stern, PhD | University of Southern California | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| USC / Norris Comprehensive Cancer Center | Recruiting | Los Angeles | California | 90033 | United States |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D017410 | Practice Guidelines as Topic |
| D059039 | Standard of Care |
| D006293 | Health Promotion |
| D004522 | Educational Status |
| ID | Term |
|---|---|
| D017408 | Guidelines as Topic |
| D011785 | Quality Assurance, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
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| Health Promotion and Education | Other | Receive CoGENES training |
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| Survey Administration | Other | Ancillary studies |
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| Baseline to 12 months |
| Intention to pursue colorectal cancer screening | Will be assessed using one question with a 5-point response option (1 = Very Unlikely, 2 = Somewhat Unlikely, 3 = Neutral, 4 = Somewhat Likely, 5 = Very Likely). | Up to 12 months |
| Intention to inquire about cancer history among family members | Will be assessed using one question with a 5-point response option (1 = Very Unlikely, 2 = Somewhat Unlikely, 3 = Neutral, 4 = Somewhat Likely, 5 = Very Likely). | Up to 12 months |
| Intention to ask healthcare provider about genetic testing and counseling | Will be assessed using one question with a 5-point response option (1 = Very Unlikely, 2 = Somewhat Unlikely, 3 = Neutral, 4 = Somewhat Likely, 5 = Very Likely). | Up to 12 months |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D017530 | Health Care Quality, Access, and Evaluation |
| D019984 | Quality Indicators, Health Care |
| D006266 | Health Education |
| D011314 | Preventive Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |